NCT02813187

Brief Summary

This is an observational, longitudinal real world registry of venous leg ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

9 years

First QC Date

June 10, 2016

Last Update Submit

April 23, 2018

Conditions

Venous Stasis UlcerQuality of Patient Care

Keywords

venous leg ulcervenousQCDRquality measurewoundOutcomeLymphedema

Outcome Measures

Primary Outcomes (1)

  • Wound Healing

    wound closure

    12 months

Secondary Outcomes (4)

  • Weeks of Therapy

    12 months

  • Adverse events during therapy

    12 months

  • Patient Reported Outcome

    12 months

  • Venous Insufficiency

    12 months

Interventions

cellular and tissue based therapyBIOLOGICAL
Also known as: Apligraf, Dermagraft, Theraskin, Epifix, Dermapure, Grafix, Talymed
debridementPROCEDURE
advanced wound therapyPROCEDURE
Nutritional screeningDIETARY_SUPPLEMENT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospectively followed venous leg ulcers in the practice of clinicians submitting data to the registry

You may qualify if:

  • All patients with venous leg ulcers seen by the practitioner.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHI St. Luke's The Woodlands

The Woodlands, Texas, 77384, United States

Location

MeSH Terms

Conditions

Varicose UlcerWounds and InjuriesLymphedema

Interventions

Cell CountApligrafTransCyteDebridement

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesCell Physiological PhenomenaSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 24, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

April 25, 2018

Record last verified: 2018-04

Locations

US(1)